OEE for Medical Device Manufacturing: A Guide to FDA & ISO 13485 Compliance

In medical device manufacturing, the stakes are higher. A quality failure isn't just a financial loss; it's a potential patient safety issue and a major compliance risk.

The goal is not just efficiency; it's a state of validated, documented, and constant control over your processes.

Paula, a QA Director, is responding to an audit finding. A machine parameter drifted out of its validated range six months ago, leading to a non-conformance.

The paper trail connecting the production event to the maintenance investigation and the final corrective action is incomplete. This puts the company at significant risk.

The Diagnosis Problem

Manual OEE data collection on a spreadsheet is indefensible in an FDA audit. It lacks the security, time-stamps, audit trails, and electronic signatures required for a compliant Device History Record (DHR).

The Integrated Solution

A modern OEE system provides the validated foundation for data integrity. It captures data directly from your machine PLCs or uses Computer Vision to create an accurate, time-stamped, and unchangeable electronic record of your entire production process.

The integrated CMMS completes the compliance picture. It provides a full, unchangeable audit trail for all maintenance actions, from routine calibrations to unscheduled repairs, complete with the electronic signatures required by 21 CFR Part 11.

The Diagnosis Problem

A traditional OEE system can diagnose a process deviation in real-time. But for a medical device manufacturer, this alert is a liability.

It starts the clock on a formal, required response that must be managed and documented perfectly according to your QMS procedures.

The Integrated Solution (The Fabrico Workflow)

The Diagnosis: The validated OEE module instantly detects a critical process deviation. This could be a machine parameter going out of its validated spec or a sudden drop in the quality rate.

The Cure: This is not just a simple alert; it's a compliance trigger. It instantly and automatically initiates a formal CAPA (Corrective and Preventive Action) workflow within the integrated CMMS.

This creates a time-stamped, unchangeable record of the event. It allows your Quality and Maintenance teams to manage every step of the investigation, root cause analysis, and corrective action in a single, validated system, providing a perfect, closed-loop record for your QMS and any auditors.

Does our OEE software need to be validated?

Yes. Any software that affects product quality, GMP compliance, or is part of your electronic Device History Record (DHR) system must be validated. It's critical to choose a vendor who can provide validation support and documentation.

How does this system help with creating our Device History Record (DHR)?

An integrated OEE + CMMS platform provides a rich source of automated, time-stamped data on machine performance, deviations, and all corrective maintenance actions. This data serves as a critical, auditable input for your official DHR for each batch or device.

Can we start by implementing this on a single cleanroom line?

Absolutely. The best approach for the medical device industry is to start with a single, validated pilot line. This allows you to prove the value, complete a focused validation process, and then roll the solution out to other lines with a proven protocol.

For medical device manufacturers, the goal is not just a high OEE score. The goal is a system that provides a state of constant, validated control.

It's a system where every production event and every maintenance response is automatically documented in a single, unified, audit-ready platform.

Ready to see how an integrated OEE and CMMS platform is designed for the unique compliance challenges of the medical device industry?

Book a personalized demo of Fabrico today.